Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia (AD). The mechanisms of agitation in AD are poorly understood and the current interventions are only modestly effective while having serious adverse effects. In this study, the investigators propose to assess the mechanisms and treatment of neuropsychiatric symptoms in AD with the use of non-invasive, brain stimulation approaches. By applying magnetic stimulation to the surface of the head (transcranial magnetic stimulation - TMS) combined with electroencephalography (EEG), the investigators will be able to study the mechanisms of agitation and advance our understanding of AD. Further, the investigators will evaluate if transcranial direct current stimulation (tDCS) is effective to treat agitation dementia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
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• Age 50 years or older.

• Participant or substitute decision maker able and willing to provide informed consent.

• Dementia due to probable or possible AD as defined by NIA-AA criteria.

• Presence of mild to moderate agitation and/or aggression as defined by: Agitation in cognitive disorders. International Psychogeriatric Association Provisional Consensus Clinical and Research Definition.

• Availability of a support person to accompany the participant to study appointments and provide collateral information as needed.

• If taking medication for neuropsychiatric symptoms, the dose should be stable for at least 1 week.

• Age 50 years or older.

• Able and willing to provide informed consent.

• Free from any significant neurological disorder.

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Gifty Asare, MSc
Gifty.Asare@camh.ca
416-535-8501
Time Frame
Start Date: 2019-04-24
Estimated Completion Date: 2025-06
Participants
Target number of participants: 90
Treatments
Experimental: Active tDCS
The direct current will be delivered at 2 mA intensity via rubber electrodes in saline- soaked sponges for 30 min per day for 2 weeks, 5 days/week. Inhibitory stimulation will be delivered to the frontal lobes.
Sham_comparator: sham tDCS
Sham tDCS will use the same parameters except that the device will automatically turn off after a certain duration.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health
Collaborators: BrightFocus Foundation

This content was sourced from clinicaltrials.gov

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